keto mojo β-ketone test strips (50pcs/box)

GUDID 00858538007004

KETO-CHECK, INC.

Ketone (acetoacetate) IVD, reagent

• Primary Device ID: 00858538007004
• NIH Device Record Key: 47e395a3-37d6-4427-87ec-af8d41da974f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: keto mojo β-ketone test strips (50pcs/box)
• Version Model Number: TD-4279
• Company DUNS: 080577376
• Company Name: KETO-CHECK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858538007004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-21

Devices Manufactured by KETO-CHECK, INC.

• 00858538007004 - keto mojo β-ketone test strips (50pcs/box): 2019-03-11
• 00858538007004 - keto mojo β-ketone test strips (50pcs/box): 2019-03-11
• 00858538007103 - keto mojo β-ketone & blood glucose monitoring system: 2019-03-11
• 00858538007202 - Keto-mojo β-ketone test strips (10pcs/box): 2019-03-11
• 00858538007301 - keto mojo glucose test strips (50pcs/box): 2019-03-11